[Congressional Record Volume 171, Number 107 (Monday, June 23, 2025)]
[House]
[Pages H2860-H2863]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SHANDRA EISENGA HUMAN CELL AND TISSUE PRODUCT SAFETY ACT
Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 1082) to require the Secretary of Health and Human Services
to conduct a national, evidence-based education campaign to increase
public and health care provider awareness regarding the potential risks
and benefits of human cell and tissue products transplants, and for
other purposes.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 1082
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Shandra Eisenga Human Cell
and Tissue Product Safety Act''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Human cell and tissue product.--The terms ``human cell
and tissue product'' and ``human cell and tissue products''
have the meaning given the term ``human cells, tissues, or
cellular or tissue-based products'' in section 1271.3(d) of
title 21, Code of Federal Regulations (or successor
regulations).
(2) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(3) Tissue reference group.--The term ``Tissue Reference
Group'' means the Tissue
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Reference Group of the Food and Drug Administration.
SEC. 3. HUMAN CELL AND TISSUE PRODUCTS TRANSPLANT PUBLIC
AWARENESS CAMPAIGN.
The Secretary shall support the development and
dissemination of educational materials to inform health care
professionals and other appropriate professionals about
issues surrounding--
(1) organ, tissue, and eye donation, including evidence-
based methods to approach patients and their families;
(2) the availability of any donor screening tests; and
(3) other relevant aspects of donation.
SEC. 4. CIVIL PENALTIES FOR VIOLATION OF REQUIREMENTS FOR
HUMAN CELL AND TISSUE PRODUCTS.
Section 368 of the Public Health Service Act (42 U.S.C.
271) is amended by adding at the end the following:
``(d)(1) Any person who, on or after the date of the
enactment of the Shandra Eisenga Human Cell and Tissue
Product Safety Act, violates a requirement of subparts C or D
of section 1271 of title 21, Code of Federal Regulations, (or
successor regulations) with respect to human cell or tissue
products regulated under section 361 shall be liable to the
United States for a civil penalty in an amount not to exceed
the sum of--
``(A)(i) $20,000 for each violation; and
``(ii) in the case of a violation that continues after the
Secretary provides written notice to such person, $20,000 for
each subsequent day on which the violation continues; and
``(B) an amount equal to the retail value of the human cell
and tissue products that are the subject of the violation.
``(2) The total civil penalty under paragraph (1) may not
exceed $10,000,000 for all such violations adjudicated in a
single proceeding.
``(3) In this subsection, the term `human cell and tissue
products' has the meaning given the term `human cells,
tissues, or cellular or tissue-based products' in section
1271.3(d) of title 21, Code of Federal Regulations (or
successor regulations).''.
SEC. 5. STREAMLINING REGULATORY OVERSIGHT OF HUMAN CELL AND
TISSUE PRODUCTS.
(a) Information on Human Cell and Tissue Products.--
(1) Website.--The Secretary, acting through the
Commissioner of Food and Drugs, shall publish on the public
website of the Food and Drug Administration--
(A) educational materials about the Tissue Reference Group;
and
(B) best practices for obtaining a timely, accurate
recommendation regarding human cell and tissue products from
the Tissue Reference Group.
(2) Public information.--Not later than 1 year after the
date of the enactment of this Act, and annually for the
subsequent 3 years, the Secretary, acting through the
Commissioner of Food and Drugs, shall publish on the public
website of the Food and Drug Administration--
(A) the number of human cell and tissue establishments that
registered with the Food and Drug Administration on or after
January 1, 2019;
(B) the number of inspections conducted by the Food and
Drug Administration of human cell and tissue establishments
on or after January 1, 2019, including a comparison of the
number of inspections for blood establishments with the
number of inspections for such human cell and tissue
establishments;
(C) the number and type of inquiries to the Tissue
Reference Group in the preceding year; and
(D) the average response time for submissions to the Tissue
Reference Group in the preceding year, including average
initial and final response time.
(3) Education.--The Secretary, acting through the
Commissioner of Food and Drugs, shall, with respect to the
regulation of human cell and tissue products--
(A) provide information to relevant stakeholders, including
industry, tissue establishments, academic health centers,
biomedical consortia, research organizations, and patients;
and
(B) conduct workshops and other interactive and educational
sessions for such stakeholders to help support regulatory
predictability and scientific advancement, as appropriate.
(b) Human Cell and Tissue Product Scientific and Regulatory
Updates.--Section 3205 of the Food and Drug Omnibus Reform
Act of 2022 (title III of division FF of Public Law 117-328)
is amended by striking ``best practices'' and all that
follows through ``other cellular therapies'' and inserting
``best practices on generating scientific data necessary to
further facilitate the development of certain human cell-,
tissue-, and cellular-based medical products (and the latest
scientific information about such products), namely, stem
cell and other cellular therapies''.
(c) Public Docket.--Not later than 60 days after the date
of the enactment of this Act, the Secretary shall establish a
public docket to receive written comments related to--
(1) the approaches recommended for discussion during the
public workshop described in section 3205 of the Food and
Drug Omnibus Reform Act of 2022 (title III of division FF of
Public Law 117-328); and
(2) modernizing the regulation of human cell and tissue
products, including considerations associated with assessing
minimal manipulation and homologous use (as such terms are
defined in section 1271.3 of title 21, Code of Federal
Regulations (or successor regulations)) of human cell and
tissue products.
(d) Report to Congress.--Not later than September 30, 2026,
the Secretary shall summarize the approaches discussed in the
public workshop described in section 3205 of the Food and
Drug Omnibus Reform Act of 2022 (title III of division FF of
Public Law 117-328) and the public docket described in
subsection (c), and develop recommendations regarding the
regulation of human cell and tissue products, including
provisions under sections 1271.10(a) and 1271.3 of title 21,
Code of Federal Regulations, taking into account--
(1) regulatory burden;
(2) scientific developments;
(3) access to human cell and tissue products regulated
under section 361 of the Public Health Service Act (42 U.S.C.
264); and
(4) protecting public health.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Florida (Mr. Bilirakis) and the gentleman from New Jersey (Mr. Pallone)
each will control 20 minutes.
The Chair recognizes the gentleman from Florida.
General Leave
Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material in the Record on this particular bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Florida?
There was no objection.
Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today in strong support of H.R. 1082, the Shandra
Eisenga Human Cell and Tissue Product Safety Act, led by my good friend
Chairman Moolenaar from the great State of Michigan. This bill was
borne out of a heartbreaking tragedy that we hope will never be
repeated again.
In 2023, a Michigan constituent died from tuberculosis caused by a
contaminated bone graft. This bill would require the HHS Secretary to
conduct a national educational campaign to increase public and
healthcare provider awareness regarding the risks and benefits of human
cell and tissue transplants.
It would also require FDA to streamline the regulatory oversight of
these particular products, including by publishing educational
materials and best practices and by conducting workshops and public
stakeholder sessions.
Ultimately, H.R. 1082 will increase public awareness, patient safety,
and public trust in these lifesaving medical products to help ensure
that preventable tragedies, like the unfortunate death of Ms. Eisenga,
do not ever occur again.
This bill passed the House unanimously last December, and I look
forward to its timely passage once again so that we can get it to the
Senate.
Mr. Speaker, let's pass this very critical bill, H.R. 1082, and I
reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of H.R. 1082, the Shandra
Eisenga Human Cell and Tissue Product Safety Act, sponsored by my
colleagues Representative Dingell and Representative Moolenaar.
Mr. Speaker, stem cell therapies and related products have shown
tremendous promise for delivering treatments to patients, such as bone
marrow transplants for certain cancer patients and therapies for
patients with blood and immune system disorders. Yet, there are still
rogue clinics that take advantage of patients who are desperate for
cures.
For example, there are reports of some clinics peddling unapproved
treatments with exaggerated and deceptive claims. Exposure to these
unproven treatments has put vulnerable patients' health at risk,
leading to serious adverse events, including blindness, bloodstream
infections, paralysis, and tumor growth.
There are currently few meaningful repercussions in the human cell
and tissue products industry. This bill would change that by providing
the Food and Drug Administration with additional enforcement tools to
more quickly and effectively protect the public. It provides a balanced
approach to improving safety of human cell tissue and cellular and
tissue-based products.
First, it provides clarity regarding FDA's scientific and regulatory
efforts to oversee these products. Second, it
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also enables more effective enforcement against an establishment that
does not meet their donor eligibility obligations or current good
tissue practice obligations.
This would also encourage responsible manufacturers to continue to
develop and license products where the scientific evidence supports the
product's safety, purity, and potency.
I support this bill, Mr. Speaker, but continue to have concerns
regarding the chaos at HHS broadly and FDA specifically. While this
bill provides the FDA with additional enforcement tools, the Trump
administration has made massive cuts to both funding and staffing at
FDA.
The President's budget doubles down on this chaos by proposing an 11
percent cut to the FDA budget and eliminating 2,000 jobs. This hinders
the FDA's ability to actually protect the public.
Again, I call on my Republican colleagues to join me in conducting
proper oversight of the Trump administration's actions. Otherwise,
bipartisan efforts like this one will be rendered meaningless. If we
are giving the agency new statutory tools and enforcement authority
because we think there is a risk to the public, then the agency must be
prepared to carry out those duties.
Mr. Speaker, I encourage all of my colleagues to vote ``yes'' on this
important bill, and I reserve the balance of my time.
{time} 1545
Mr. BILIRAKIS. Mr. Speaker, I yield such time as he may consume to
the gentleman from Michigan (Mr. Moolenaar), my good friend and the
chairman of the select committee on China. I am very proud to serve
under his leadership.
Mr. MOOLENAAR. Mr. Speaker, I thank the gentleman from Florida (Mr.
Bilirakis) for yielding and for his strong support for this
legislation. I also thank my colleagues on the other side of the aisle,
Mr. Pallone, and especially my friend and fellow Michigander,
Congresswoman Debbie Dingell, who has worked very closely with me on
this legislation.
Mr. Speaker, I rise in support of this bipartisan legislation, H.R.
1082, the Shandra Eisenga Human Cell and Tissue Product Safety Act.
In 2023, 36 patients across 7 States contracted tuberculosis after
receiving bone grafts containing infected donor material.
One of these patients was my constituent, Shandra Eisenga, of Marion,
Michigan, who tragically passed away on August 10, 2023, due to
complications from TB.
I was proud to have Shandra's family here last year when this
legislation was first considered by the House. This family has been
forever hurt by the loss of Shandra. Her daughter, Amber, said: Nothing
can erase the heartbreak of my mother's passing, but she would be proud
that we have helped make a positive difference in her name.
Today, we are taking concrete action to prevent more families from
having the same experience as Amber and to honor her mother's legacy.
Shandra's passing was completely preventable. So were the deaths of
nine other patients who have passed away from TB since 2021 because of
inadequate oversight of tissue material suppliers.
When it comes to tissue donations, the FDA requires screening for
diseases like hepatitis, syphilis, and HIV. This bipartisan bill will
require screening for tuberculosis, as well, and put an end to
preventable TB deaths like Shandra's.
The bill will also require HHS to conduct research and public
education campaigns on the risks of surgery requiring a tissue
donation.
Mr. Speaker, I urge my colleagues to support this vital bipartisan
legislation in honor of Shandra and her family.
Mr. PALLONE. Mr. Speaker, I yield such time as she may consume to the
gentlewoman from Michigan (Mrs. Dingell).
Mrs. DINGELL. Mr. Speaker, I rise today to share my strong support of
H.R. 1082, the Shandra Eisenga Human Cell and Tissue Product Safety
Act.
I am very proud to lead this bill with my good friend and colleague
from Michigan, Representative John Moolenaar. Both of us have been
very personally involved with the family and learning where there are
serious deficiencies within our government.
In the summer of 2023, I was contacted by the medical director of the
Washtenaw County Tuberculosis Clinic and head of public health who was
treating Shandra for a severe postsurgical tuberculosis infection. She
was Representative Moolenaar's constituent but was being treated at a
medical facility in my district. After a month battling a severe TB
infection in the intensive care unit, Shandra unfortunately died.
Since Shandra's passing, it has been discovered that her death was,
indeed, linked to contaminated bone graft material. She was 1 of 36
patients who received material from the contaminated lot, and this
latest outbreak is linked to the deaths of two patients, including
Shandra.
It had been preceded 2 years before by an outbreak, again, linked to
contaminated bone allografts, which resulted in multiple deaths. The
outbreak then infected 113 patients across 18 States, and it led to at
least 3 confirmed TB-related deaths with some sources citing a total of
8 deaths.
This has to stop. Too many people get bone grafts and have no idea,
including the doctor that did a bone graft on me, that they even needed
to worry about this.
This bill requires the Department of Health and Human Services to
conduct research and education campaigns to prevent TB outbreaks caused
by contaminated human cell and tissue product donations.
Through the markup process, we have also included an important
provision to allow the Federal Government to pursue civil penalties
from providers who caused an outbreak of the infectious disease.
Patients deserve to know the risks associated with tissue donations and
companies that make and distribute contaminated products must be held
accountable for their actions.
Mr. Speaker, I thank the Energy and Commerce Committee Chair Guthrie,
my dear friend Mr. Bilirakis, and Ranking Member Pallone for fighting
for this important piece of legislation.
Again, I thank Representative Moolenaar for being such a great
bipartisan partner. We owe it to Shandra, her family, and every other
patient who has been affected by contaminated bone grafts to ensure we
are doing everything we can to prevent these unnecessary tragedies from
ever happening again.
Mr. Speaker, I urge my colleagues to vote ``yes'' on this important
bill.
Mr. PALLONE. Mr. Speaker, I urge support of this important
legislation on a bipartisan basis, and I yield back the balance of my
time.
Mr. BILIRAKIS. Mr. Speaker, in closing, I encourage a ``yes'' vote on
this particular piece of legislation, and I yield back the balance of
my time.
Mr. CARTER of Georgia. Mr. Speaker, I rise today in strong support of
the Shandra Eisenga Human Cell and Tissue Product Safety Act, which is
a critical piece of legislation aimed at preventing tuberculosis
infections linked to tissue transplants.
In 2023, 36 patients across seven States contracted tuberculosis from
infected bone grafts.
One of these patients was Shandra Eisenga, who tragically passed away
on August 10, 2023, from tuberculosis, or TB.
This bipartisan bill requires the Department of Health and Human
Services to conduct public awareness campaigns to assist in preventing
TB outbreaks caused by contaminated human cell and tissue product
donations.
Shandra's death was a preventable tragedy, and we will honor her
memory by strengthening guidelines and improving education for these
medical products, so no other family has to suffer through this again.
Mr. Speaker, I encourage my colleagues to support this bill.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Florida (Mr. Bilirakis) that the House suspend the rules
and pass the bill, H.R. 1082.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill was passed.
A motion to reconsider was laid on the table.
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